83544 Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 

SUMMARY: The Office of Early Childhood 

Development (ECD), Administration for 

Children and Families (ACF), U.S. 

Department of Health and Human 

Services (HHS), is requesting Office of 

Management and Budget (OMB) 

approval of the Tribal Early Childhood 

Facilities Combined Application Guide 

for joint applications for construction 

and major renovation projects using 

both Head Start and Child Care and 

Development Fund (CCDF) resources. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, ACF is soliciting 

public comment on the specific aspects 

of the information collection described 

above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

infocollection@acf.hhs.gov. Identify all 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: Funding for facilities 

under the CCDF is authorized by section 

658O(c)(6) of the Child Care and 

Development Block Grant (CCDBG) Act, 

42 U.S.C. 9858(c)(6), and is managed by 

the Office of Child Care (OCC). Funding 

for Head Start facilities projects is 

authorized by 45 CFR part 1303 (subpart 

E) Head Start Program Performance 

Standards and is managed by the Office 

of Head Start (OHS). The guide 

streamlines the process for Tribal CCDF 

Lead Agencies and American Indian 

and Alaska Native (AI/AN) Head Start 

programs submitting collaborative, joint 

applications to use federal CCDF and 

Head Start funds for facilities projects 

where funds can be used for reasonable 

costs and fees related to planning for a 

facilities project and to support the 

application development in tribal 

communities. Both funds aim to 

construct or improve early childhood 

facilities, often serving the same 

children, but application submission 

and review processes are currently 

unique to each respective funding 

stream. The proposed information 

collection will provide instructions to 

Tribal CCDF Lead Agencies and AI/AN 

Head Start programs on submitting joint 

plans for how proposed facilities 

projects will enable the programs to 

better serve current AI/AN families or 

increase enrollment currently limited by 

inadequate facilities. The guide will 

provide critical information and 

resources, so recipients understand the 

requirements of each program and 

develop plans that reflect the needs of 

their communities. Reducing and 

streamlining administrative burdens for 

tribal constituents follows policy 

priorities laid out in the 2022 HHS 

Equity Action Plan and is in alignment 

with Executive Order 14095—Executive 

Order on Increasing Access to HighQuality Care and Supporting Caregivers. 

Respondents: AI/AN Head Start 

Facilities and Tribal CCDF Lead 

Agencies (information collection does 

not include direct interaction with 

individuals or families that receive the 

services). 

Annual Burden Estimates: We 

estimate at most 10 applications per 

year and have estimated burden based 

on this maximum number. 

Instrument Total number 

of respondents 

Annual number 

of responses 

per respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Tribal Early Childhood Facilities Application Guide ................................. 10 1 100 1,000 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 42 U.S.C. 9858(c)(6); 45 

CFR part 1303 subpart E. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–26307 Filed 11–29–23; 8:45 am] 

BILLING CODE 4184–87–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Survey of Staff Recruitment, 

Training, and Professional 

Development in Early Head Start (New 

Collection) 

AGENCY: Office of Planning, Research, 

and Evaluation, Administration for 

Children and Families, U.S. Department 

of Health and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Administration for 

Children & Families (ACF) at the U.S. 

Department of Health and Human 

Services (HHS) seeks approval to 

conduct a nationally representative 

survey of Early Head Start (EHS) grant 

recipients regarding their recruitment, 

hiring, and professional development 

practices. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act of 1995, the ACF is 

soliciting public comment on the 

specific aspects of the information 

collection described above. 

ADDRESSES: You can obtain copies of the 

proposed collection of information and 

submit comments by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: The Survey of Staff 

Recruitment, Training, and Professional 

Development in EHS is a nationally 

representative survey that will describe 

how EHS programs ensure staff have the 

qualifications and competencies to 

deliver high-quality services to infants, 

toddlers, and their families. The 

information collection will examine 

how EHS grant recipients search for and 

hire qualified teaching and home 

visiting staff and support staff in their 

ongoing professional development and 

career advancement. The information 

collection aims to identify successful 

strategies or approaches as well as 

challenges faced as EHS programs 

search for, hire, and train teaching and 

home visiting staff. Findings are 

intended to inform program planning, 

training and technical assistance, and 

research. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 229 / Thursday, November 30, 2023 / Notices 83545 

Respondents: EHS program directors 

or their designee. 

Annual Burden Estimates: 

Instrument 

Number of 

respondents 

(total over 

request period) 

Number of 

responses per 

respondent 

(total over 

request period) 

Average burden 

per response 

(in hours) 

Total/annual 

burden 

(in hours) 

Survey instrument for center-based programs only ................ 232 1 .5 116 

Survey instrument for home-based programs only ................. 56 1 .5 28 

Survey instrument for programs with center-based and 

home-based options ............................................................. 312 1 .75 234 

Estimated Total Annual Burden 

Hours: 378. 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: Head Start Act section 640 

[42 U.S.C. 9835]. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–26297 Filed 11–29–23; 8:45 am] 

BILLING CODE 4184–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2022–E–0656; FDA– 

2022–E–0657; FDA–2022–E–0658; FDA– 

2022–E–0659; FDA–2022–E–0660; and FDA– 

2022–E–0680] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; Amondys 45 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for Amondys 45 and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by January 29, 2024. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

May 28, 2024. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

January 29, 2024. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket Nos. FDA– 

2022–E–0656; FDA–2022–E–0657; 

FDA–2022–E–0658; FDA–2022–E–0659; 

FDA–2022–E–0660; FDA–2022–E–0680 

for ‘‘Determination of Regulatory 

Review Period for Purposes of Patent 

Extension; AMONDYS 45.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 


khammond on DSKJM1Z7X2PROD with NOTICES